Shame!

A commentary by Steve Snyder

[EDITOR'S NOTE: Mr. Snyder's commentary does not necessarily reflect the opinions of Contract Pharma LLC or any of its staff, but as the editor of this magazine and website, I decided that his opinion deserved a voice. If you'd like to discuss this column, or you have an issue with the facts and opinions as they're presented here, please e-mail me or Steve. --GYR]

I can’t do it. I can’t do it. I cannot sit by and not comment about the incredibly sad news that we learned of today. As I write this, it is 9:42 pm on Friday, August 8, 2008 and I would like to believe that I just developed a backbone. It would have been easier for me to keep my disgust to myself and not attract unwanted attention . . . but I can’t do it.

Today the public and the drug research community learned of what was described as an accident at Charles River’s research facilities in Reno, NV. Thirty-two monkeys died due to a climate control problem in the facility. They died because of excessive heat in the room where they were housed. The company reports that this accident occurred on May 28 but it was only announced today, more than two months later. The company indicated that it delayed the public announcement out of concern for the safety of its employees and the remaining animals in the facility . . . which we pray are still alive. In the interest of full disclosure, I worked at Charles River from June 2002 until December 2003. I am sure that after you read what I will share below, some will say that my comments are based on “sour grapes” or that I am maladjusted in some way. Fine. Say what you will. It will not change the facts.

I have worked in various roles in drug development for more than 30 years and I would be the first to tell anyone that mistakes do happen. Preclinical drug development is an incredibly complex and detailed operation. Many of us who work in preclinical drug development are avid — maybe even obsessive — animal lovers. This is what makes today’s news so sad. Yes, mistakes do happen but what we learned of today is sickening and deplorable. During the earnings announcement earlier this week, the company's chief executive officer Jim Foster stated that, “Our clients are very impressed with the state-of-the-art facility and its staff.” Note that Foster’s statement was made over two months after this accident occurred and, conveniently, a couple days before the company finally shared the news with the public. I guess Charles River determined that the safety of their staff was significantly improved after they announced their financial results?

I never dreamed that I would agree with someone from PETA. You would think that a “state-of-the-art facility” would have alarms to alert the staff when environmental parameters go out of established ranges. I know the facilities of Charles Rivers’s competitors have this safety feature in place. Maybe there was an alarm, but the catch about alarms is that people need to react when it activates. I am no expert in HVAC systems, but I am very experienced in facility operations and no one has explained why the facility staff was not aware of this circumstance. Even without alarms, part of our obligation in participating in this research is to make sure that the animals are afforded the best care possible. This includes routinely checking on the welfare of the animals every single day. This was a royal screw-up and it is insulting to those of us that work in this industry. I have received phone calls and e-mail messages all day today from colleagues in the industry who are sickened and angry about this news.

If you follow my regular column in Contract Pharma, I have always taken great measures not to name specific companies especially when I am expressing my concerns about the drug development industry. This is different. Not only do we have to deal with the report that 32 animals died due to negligence, but we must also address Charles River’s willful decision to keep this information from the public and the research community. The industry has regulations to help assure the quality of data and to assure that research animals are provided the best care possible. While it appears that there is no evidence of regulatory non-compliance on the part of Charles River, the company's decision to delay the reporting of this incident violates the laws of trust. In my opinion, this deplorable incident is what happens when revenue growth is put ahead of doing the right things the right way. You can’t buy trust and integrity. Quietly, the preclinical drug research community mourns tonight and it didn’t have to be this way.

RESPONSE:

One reader (name withheld by request) responds: "This commentary has factual errors or omissions. The HVAC technical person was at the old Reno facility, not the new state-of-the-art facility that CRL built. The HVAC person turned on the heat to work on the system, and left for the day without turning the heat down. The alarm did go off. For some unexplained reason, the security did not respond (similar to what happened in the primate house at the Philadelphia Zoo a few years ago). The result was tragic. The facility in question was the oldest of the many buildings in the Sparks facility that has been in use for years. The oldest building was used for quarantine of the new arrivals."

Steve Snyder is a consultant with more than 25 years of experience in preclinical toxicology as an outsourcing customer and provider. He writes the Preclinical Outsourcing column for Contract Pharma.

Kristin Brooks, Contract Pharma||May 19, 2015Niall Dinwoodie of Charles River discusses several key industry issues on biosimilars and addresses some of the development and regulatory hurdles that remain